criteria Fulfill
Item
to be included in the study, patients must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Prostate carcinoma Biopsy sample
Item
1. cancer of the prostate confirmed by a biopsy sample.
boolean
C0600139 (UMLS CUI [1,1])
C0677862 (UMLS CUI [1,2])
Age
Item
2. 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Neoplasm Metastasis | Plain chest X-ray | CT of abdomen | Computed Tomography (CT) of Pelvis | scan of bone | examination; clinical
Item
3. disease must have spread beyond the prostate as proven by chest x ray, abdominal and pelvic computed tomography (ct) scan, bone scan or clinical examination.
boolean
C0027627 (UMLS CUI [1])
C0039985 (UMLS CUI [2])
C0412620 (UMLS CUI [3])
C0412628 (UMLS CUI [4])
C0203668 (UMLS CUI [5])
C1456356 (UMLS CUI [6])
Hormone Therapy | Disease Progression
Item
4. at least one prior hormonal treatment with documented disease progression during hormone therapy.
boolean
C0279025 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Taxotere | Chemotherapy | Combined Modality Therapy | Estramustine
Item
5. one previous line of chemotherapy that included taxotere® (as monotherapy or in combination). this could be in addition to estramustine single agent therapy.
boolean
C0699967 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0014921 (UMLS CUI [4])
Taxotere | Disease Progression
Item
6. disease progression during prior taxotere-based therapy or within 3 months of discontinuing.
boolean
C0699967 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Toxic effect Chemotherapy Related | Toxic effect Therapeutic radiology procedure Related | Toxic effect Operative Surgical Procedure Related | Patient Recovered
Item
7. recovered from any toxic effects of prior chemotherapy, radiotherapy and surgery.
boolean
C0600688 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0521108 (UMLS CUI [4,2])
Toxic effect Investigational New Drugs Related | Patient Recovered
Item
8. recovered from any toxic effects associated with other investigational drugs, if applicable.
boolean
C0600688 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
Informed Consent
Item
9. signed informed consent obtained prior to initiation of any study-specific procedures or treatment.
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status | criteria Fulfill
Item
patients cannot participate in the study if any of the following apply:
boolean
C2348568 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Prednisone Use Unable
Item
1. unable to use prednisone.
boolean
C0032952 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
irofulven | capecitabine | Xeloda | Fluorouracil Infusion Duration | fluoropyrimidine | Mitoxantrone
Item
2. prior treatment with irofulven, capecitabine (xeloda), continuous/protracted infusion 5-fu (5-fluorouracil) (infusion duration greater than or equal to 24 hours), other fluoropyrimidines or mitoxantrone.
boolean
C0532362 (UMLS CUI [1])
C0671970 (UMLS CUI [2])
C0724419 (UMLS CUI [3])
C0016360 (UMLS CUI [4,1])
C0574032 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
C0596581 (UMLS CUI [5])
C0026259 (UMLS CUI [6])
Steroid therapy Dose Prednisone Equivalent
Item
3. ongoing treatment with a corticosteroid at a prednisone-equivalent dose > 10 mg/day.
boolean
C0149783 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
C0205163 (UMLS CUI [1,4])
Sm153 | Strontium-89 | Radionuclide therapy
Item
4. more than 1 prior treatment with either 153sm or 89sr, or radioisotope treatment within 8 weeks prior to entering this study.
boolean
C0677942 (UMLS CUI [1])
C0281385 (UMLS CUI [2])
C0203608 (UMLS CUI [3])
Diphosphonates | pamidronate | Etidronate
Item
5. initiation of treatment with bisphosphonate agents (e.g., pamidronate, etidronate) within 2 months of entering the study. pre-existing treatment with bisphosphonate agents is to be continued during this study.
boolean
C0012544 (UMLS CUI [1])
C0043603 (UMLS CUI [2])
C0086268 (UMLS CUI [3])
Warfarin | Phenytoin
Item
6. treatment with warfarin and/or phenytoin within 14 days before entering this study or during the study period.
boolean
C0043031 (UMLS CUI [1])
C0031507 (UMLS CUI [2])
Clinical Trial Eligibility Criteria Additional
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if patients meet all of the criteria. if patients do not qualify for the trial, study personnel will explain the reasons. if patients do qualify, study personnel will explain the trial in detail and answer any questions. patients can then decide if they wish to participate.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])